Guardant Health announced that it received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to provide genomic testing for a clinical trial investigating the small molecule, c-Met kinase inhibitor tepotinib. Under a collaboration agreement between Guardant Health and Merck KGaA, Darmstadt, Germany—which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada—the Guardant360 CDx Test will be the liquid biopsy option to identify advanced lung cancer patients with MET exon 14 skipping alterations who may qualify for the ongoing Phase II tepotinib trial.
"This is an important milestone for Guardant Health in our ongoing work with the FDA," said Helmy Eltoukhy, Guardant Health's CEO. "We are very excited to partner with Merck KGaA, Darmstadt, Germany to help accelerate their study of this promising targeted agent."
Clinical trial progress is often impeded by the need to collect tumor tissue samples for genotyping. Difficulty in acquiring these samples can slow trial enrollment and prevent researchers from quickly and easily identifying the right patients. Comprehensive analysis of genomic alterations in cancer found in circulating tumor DNA obtained through a simple blood draw can eliminate the need for an invasive biopsy to acquire a tissue specimen and accelerate clinical trial enrollment.
The Guardant360 assay is the most ordered comprehensive liquid biopsy. It was introduced in 2014 and has since been used more than 50,000 times by more than 3,500 oncologists. The Guardant360 assay includes 73 genes associated with cancer, and can detect single nucleotide variants, insertion and deletion events, copy number amplifications, and fusions.